Investigations
UroGen Pharma Ltd.
Overview
Overview
- Deadline:
- Jul 28, 2025
| Company Name: | Company Name: UroGen Pharma Ltd. |
| Stock Symbol: | Stock Symbol: URGN |
UroGen Pharma Ltd. (NASDAQ: URGN): UroGen Pharma Ltd. (“UroGen” or the “Company”) and certain of the Company’s senior executives have been sued for violations of the federal securities laws. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in UroGen securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned Cockrell v. UroGen Pharma Ltd., et al., No. 3:25-cv-06088.
If you incurred losses on your investments in UroGen, you are encouraged to submit your information.
Why was UroGen Sued for Securities Fraud?
UroGen develops treatments for specialty cancers. The Company’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. One of the Phase 3 trials for UGN-102 is named ENVISION.
During the relevant period, UroGen stated that the ENVISION trial met its primary endpoint. The Company also claimed that the ENVISION trial was designed based on the Company’s “dialogue” with the FDA and that the agency had accepted the “single-arm approach.” What’s more, UroGen stated it had reached “agreement with the FDA” that the ENVISION trial would support an NDA submission.
As alleged, in truth, the FDA had previously expressed significant concerns to UroGen regarding the ENVISION trial, which lacked a concurrent control arm. The FDA had recommended a randomized trial design to UroGen “several times,” but UroGen “chose not to conduct a trial with a design and endpoints that the FDA considered appropriate.”
The Stock Declines as the Truth is Revealed
On May 16, 2025, the FDA published a briefing document stating that it doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In pertinent part, the FDA stated that because “ENVISION lacked a concurrent control arm,” the primary endpoints were “difficult to interpret.” The FDA also said it had “recommended a randomized trial design to the Applicant several times during their product’s development due to concerns with interpreting efficacy results” but UroGen “chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.” On this news, the price of UroGen stock declined $2.54 per share, or nearly 26%, from a closing price of $9.85 per share on May 15, 2025, to $7.31 per share on May 16, 2025.
Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk profile of UGN-102 was not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock declined $3.37 per share, or nearly 45%, from a closing price of $7.54 per share on May 20, 2025, to $4.17 per share on May 21, 2025.
What are my Rights?
If you purchased or otherwise acquired UroGen securities, you may ask the Court no later than July 28, 2025, which is the first business day after 60 days from the date of the publication of notice of pendency of the action, to appoint you as Lead Plaintiff through counsel of your choice. To be a member of the Class, you need not take any action at this time. The ability to share in any potential future recovery is not dependent on serving as Lead Plaintiff.
If you incurred losses on your investments in UroGen, you are encouraged to submit your information to speak with an attorney about your rights.
You can also contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619
All representation is on a contingency fee basis. Shareholders are not responsible for any court costs or expenses of litigation. The Firm will seek court approval for any potential fees and expenses.
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.
Attorney advertising. Past results do not guarantee future outcomes.
If you incurred losses on your investments in UroGen, you are encouraged to submit your information.
Why was UroGen Sued for Securities Fraud?
UroGen develops treatments for specialty cancers. The Company’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. One of the Phase 3 trials for UGN-102 is named ENVISION.
During the relevant period, UroGen stated that the ENVISION trial met its primary endpoint. The Company also claimed that the ENVISION trial was designed based on the Company’s “dialogue” with the FDA and that the agency had accepted the “single-arm approach.” What’s more, UroGen stated it had reached “agreement with the FDA” that the ENVISION trial would support an NDA submission.
As alleged, in truth, the FDA had previously expressed significant concerns to UroGen regarding the ENVISION trial, which lacked a concurrent control arm. The FDA had recommended a randomized trial design to UroGen “several times,” but UroGen “chose not to conduct a trial with a design and endpoints that the FDA considered appropriate.”
The Stock Declines as the Truth is Revealed
On May 16, 2025, the FDA published a briefing document stating that it doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In pertinent part, the FDA stated that because “ENVISION lacked a concurrent control arm,” the primary endpoints were “difficult to interpret.” The FDA also said it had “recommended a randomized trial design to the Applicant several times during their product’s development due to concerns with interpreting efficacy results” but UroGen “chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.” On this news, the price of UroGen stock declined $2.54 per share, or nearly 26%, from a closing price of $9.85 per share on May 15, 2025, to $7.31 per share on May 16, 2025.
Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk profile of UGN-102 was not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock declined $3.37 per share, or nearly 45%, from a closing price of $7.54 per share on May 20, 2025, to $4.17 per share on May 21, 2025.
What are my Rights?
If you purchased or otherwise acquired UroGen securities, you may ask the Court no later than July 28, 2025, which is the first business day after 60 days from the date of the publication of notice of pendency of the action, to appoint you as Lead Plaintiff through counsel of your choice. To be a member of the Class, you need not take any action at this time. The ability to share in any potential future recovery is not dependent on serving as Lead Plaintiff.
If you incurred losses on your investments in UroGen, you are encouraged to submit your information to speak with an attorney about your rights.
You can also contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619
All representation is on a contingency fee basis. Shareholders are not responsible for any court costs or expenses of litigation. The Firm will seek court approval for any potential fees and expenses.
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.
Attorney advertising. Past results do not guarantee future outcomes.